Coalition for Affordable Drugs IV LLC – Exhibit 1019
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`U.S. Application No. 13/340,522
`Response to Final Office Action mailed November 1, 2013
`Page 2 of 8
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`Attorney Docket No. 25922-819.301
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`AMENDMENTS TO THE CLAIMS
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`LISTING OF THE CLAIMS:
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`131.
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`(Currently Amended) A method for treating mantle cell lymphoma a relapsed or
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`refractory hematological malignancy in an individual who has already received at least one prior
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`therapy for mantle cell lymphoma comprising administering to the individual once per day
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`between about 420 mg to about 840 mg of an oral dose of a therapeutically effective amount of
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`an inhibitor of Bruton' s tyrosine kinase (Btk) having the structure:
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`132.-149. (Cancelled)
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`150.
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`(New) The method of claim 131, wherein the once per day oral dose is about 560 mg.
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`U.S. Application No. 13/340,522
`Response to Final Office Action mailed November 1, 2013
`Page 3 of 8
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`REMARKS
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`Attorney Docket No. 25922-819.301
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`Claims 131 and 150 are currently pending. Applicants have herein amended Claim 131
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`and added new Claim 150, which depends from Claim 131. Claims 132-149 are cancelled herein.
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`Support for the claim amendments can be found throughout the specification and claims as
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`originally filed, such as, for example paragraphs [0005], [00194] and [00195], and claims 62 and
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`65 as originally filed. No new matter has been added. Applicants reserve the right to pursue any
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`withdrawn or cancelled subject matter, or no longer claimed or as-yet unclaimed subject matter,
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`in this or a related application. Applicants respectfully request reconsideration of the claims as
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`amended in view of the following arguments.
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`I. Examiner Interview
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`Applicants thank the Examiner for the telephone conference of December 2, 2013, during
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`which the currently pending rejections and claims of the instant application were discussed. In
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`view of this discussion, Applicants submit herein amendments to the claims and Response to the
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`Final Office Action mailed November 1, 2013.
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`II. Rejection of the claims under 35 U.S.C. § 103
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`Claims 131, 132, 134-140, 144, 146-149 are rejected under 35 U.S.C. § 103(a) as being
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`unpatentable over Honigberg, et al. (US 2008/0076921, already of record) in view of
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`PRNewswire (Dec 2009) and Poll yea et al. (Poster Abstracts, Dec. 3, 2009, 51 st ASH Annual
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`Meeting and Exposition) and further view of Hiddeman, et al. (Seminars in Oncology, 30, 1, 2,
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`Feb 2003, p 16-20).
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`The rejection is moot with respect to claims 132, 134-140, 144, and 146-149, which are
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`cancelled herein.
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`Applicants respectfully traverse the rejection with respect to claim 131.
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`A. Relevant Law
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`It is the burden of the Office to establish that the claimed subject matter is prima facie
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`obvious. MPEP §§ 2141, 2142. To meet this burden, the Office must present prior art references
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`that teach, suggest, or otherwise provide a reason for all the claim limitations. In re Wilson, 424
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`F.2d 1382, 1385 (CCPA 1970); MPEP § 2143.03. Moreover, the teaching to make the claimed
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`combination and a reasonable expectation of success must both be found in the prior art and not
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`based on the applicant's disclosure. In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991).
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`U.S. Application No. 13/340,522
`Response to Final Office Action mailed November 1, 2013
`Page 4 of 8
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`Attorney Docket No. 25922-819.301
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`The Supreme Court instructs, "a patent composed of several elements is not proved
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`obvious merely by demonstrating that each of its elements was, independently, known in the
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`prior art." KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also MPEP § 2143.01.
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`Rather, to establish a prima facie case of obviousness, basic criteria must be met. The prior art
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`references or the combination of the prior art references with the knowledge of an ordinary
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`artisan, must suggest all of the claim limitations. See, e.g., Dann v. Johnston, 425 U.S. 219, 230
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`(1976). Moreover, there must be some predictability allowing a reasonable expectation of
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`success in making the combination. See, e.g., PharmaStem Therapeutics, Inc. v. ViaCell, Inc.,
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`491F.3d1342, 1360 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 416); MPEP § 2143.02.
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`Importantly, "rejections on obviousness cannot be sustained by mere conclusory statements;
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`instead, there must be some articulated reasoning with some rational underpinning to support the
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`legal conclusion of obviousness." KSR, 550 U.S. at 418 (quoting In re Kahn, 441F.3d977, 988
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`(Fed. Cir. 2006)).
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`B. Rejected Claims
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`Claim 1 recites:
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`A method for treating mantle cell lymphoma in an individual who has already
`received at least one prior therapy for mantle cell lymphoma comprising
`administering to the individual once per day between about 420 mg to about 840
`mg of an oral dose of an inhibitor of Bruton' s tyrosine kinase (Btk) having the
`structure:
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`Claim 150 depends from claim 1 and thus requires all limitations of the base claim. Claim
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`150 specifies that the Btk inhibitor is administered once per day oral dose is about 560 mg.
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`C. None of the cited references either alone or in combination teaches or suggests
`claimed method.
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`Applicants respectfully submit that none of the cited references either alone or in
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`combination teaches or suggests every element of the method as claimed. Specifically, none of
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`U.S. Application No. 13/340,522
`Response to Final Office Action mailed November 1, 2013
`Page 5 of 8
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`Attorney Docket No. 25922-819.301
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`the cited references either alone or in combination teaches or suggests a method for treating
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`mantle cell lymphoma in an individual who has already received at least one prior therapy for
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`mantle cell lymphoma comprising administering to the individual once per day between about
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`420 mg to about 840 mg of an oral dose of ibrutinib.
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`Relapsed or refractory MCL is a difficult disease to treat. In the attached article, Howard
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`describes mantle cell lymphoma as "incurable with standard therapeutic techniques and also has
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`an aggressive natural history that places it on par with the more aggressive forms of NHL"
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`(Howard, 0. "Mantle Cell Lymphoma," Malignant Lymphomas Ed. Grossbard, ML, London: BC
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`Decker Inc 2002 135-151, 135). Howard also states that "mantle cell lymphoma is an insidious
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`disease characterized by the aggressive natural history of the intermediate/high grade NHLs yet
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`possessing the resistance to therapy of the low-grade NHLs (page 147). Thus, MCL has the
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`worst properties of both the indolent and aggressive NHLs. The average survival rates of patients
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`with MCL are low (see Table 9-1 of Howard). In addition, Howard states that "there is no clear
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`evidence that standard dose chemotherapy regimens result in long-term DPS for patients with
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`MCL."
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`In contrast to then existing therapies for relapsed/refractory MCL, treatment of
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`relapsed/refractory MCL with ibrutinib resulted in an overall response rate of 68 percent with 21
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`percent of patients achieving a complete response and 47% achieving a partial response in a
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`phase II trial (see attached Science Daily article entitled "Drug shows surprising efficacy as
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`treatment for Chronic Leukemia, Mantle Cell Lymphoma, Science Daily,
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`http://www.sciencedaily.com/releases/2013/06/ 130619195217; see also Byrd et al. NEJM, 2013
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`Aug 8;369(6):507-16). The estimated survival of the patients was high at 58% at 18 months. The
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`response rate is considered remarkable given that that prior treatments for R/R MCL had only a
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`30% response rate. Such results are not taught or suggested by the cited art.
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`In view of these remarkable clinical results achieved, the FDA recently granted ibrutinib
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`rare breakthrough status designation. Such designation requires preliminary clinical evidence
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`that indicates that the drug may demonstrate substantial improvement over existing therapies.
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`That ibrutinib demonstrates substantial improvement over existing therapies is not taught or
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`suggested by the cited art. Such results are unexpected.
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`U.S. Application No. 13/340,522
`Response to Final Office Action mailed November 1, 2013
`Page 6 of 8
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`Attorney Docket No. 25922-819.301
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`In summary, none of the cited references either alone or in combination teaches or
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`suggests each element of the method as claimed. Accordingly, Applicants respectfully request
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`withdrawal of the rejection in view of the arguments presented herein.
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`III. Obviousness-type Double Patenting
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`A. U.S. Application No. 13/153,291(page16 of the Office Action)
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`The Examiner provisionally rejected claims 131, 132, 134-140, 143, 144, 146-149 on the
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`ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1,
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`16, and 17 of co-pending U.S. Application No. 13/153,291 (Attorney Docket No. 25922-
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`817.201) in view of PRNewswire (Dec 2009) and Pollyea, et al. (Poster Abstracts, Dec. 3, 2009,
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`51 st ASH Annual Meeting and Exposition) and further in view of Hiddeman, et al. (Seminars in
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`Oncology, 30, 1, 2, Feb 2003, p 16-20). Applicants respectfully submit that the instant claims are
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`directed to a method for treating mantle cell lymphoma (MCL), while the claims of co-pending
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`U.S. Application No. 13/153,291 are directed to a method for treating diffuse large B-cell
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`lymphoma, activated B cell-like subtype (ABC-DLBCL). MCL is a cancer that is distinct from
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`ABC-DLBCL. Because the claims are directed to two different types of cancer, Applicants
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`respectfully submit that no issue of obviousness-type double patenting exists.
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`Applicants respectfully request withdrawal of the rejection of the claims of the instant
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`application over the claims co-pending U.S. Application No. 13/153,291 for obviousness-type
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`double patenting.
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`B. U.S. Application No. 13/153,317 (page 20 of the Office Action)
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`The Examiner provisionally rejected claims 131, 132, 134-139, and 145-149 on the
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`ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1,
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`2, 5-7, 15, 24, 25, 29, 30, 33, 34, 36, 37, 48-58 of co-pending U.S. Application No. 13/153,317
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`(Attorney Docket No. 25922-819.201). Although applicants disagree with the above assertion,
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`in order to move the instant case forward, applicants herewith submit a terminal disclaimer of the
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`instant application over co-pending U.S. Application No. 13/153,317.
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`C. U.S. Application No. 13/747,319 (page 21 of the Office Action)
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`The Examiner provisionally rejected claims 131, 132, 134-139, 144 and 146-149 on the
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`ground of nonstatutory obviousness-type double patenting as being unpatentable over claims
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`130, 131, 134, 145, 147, 150 and 151 of co-pending U.S. Application No. 13/747,319 (Attorney
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`Docket No. 25922-819.304). Although applicants disagree with the above assertion, in order to
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`U.S. Application No. 13/340,522
`Response to Final Office Action mailed November 1, 2013
`Page 7 of 8
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`Attorney Docket No. 25922-819.301
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`move the instant case forward, applicants herewith submit a terminal disclaimer of the instant
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`application over co-pending U.S. Application No. 13/747,319.
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`D. U.S. Application No. "13/736,812" (page 23 of the Office Action)
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`On page 23 of the Office Action, the Examiner provisionally rejected claims 131, 132,
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`134-140, 143, 144, and 146-149 on the ground of nonstatutory obviousness-type double
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`patenting as being unpatentable over claims 130, 131, 133, 134, 145, 147, 150 and 151 of co(cid:173)
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`pending U.S. Application No. "13/747,319". The Examiner states that that claims are directed to
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`treatment of an individual having received at least two anticancer agents prior to administration
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`of the irreversible Btk inhibitor. From this description, it appears that the Examiner intended to
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`cite U.S. Application No. 13/736,812 (Attorney Docket No. 25922-819.303), not U.S.
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`Application No. 13/747,319, which already was cited on page 21 of the Office Action. Although
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`applicants disagree with the above assertion, in order to move the instant case forward,
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`Applicants herewith submit a terminal disclaimer of the instant application over co-pending U.S.
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`Application No. 13/736,812.
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`U.S. Application No. 13/340,522
`Response to Final Office Action mailed November 1, 2013
`Page 8 of 8
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`Attorney Docket No. 25922-819.301
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`CONCLUSION
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`Applicants respectfully solicit the Examiner to expedite prosecution of this patent
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`application to issuance. Should the Examiner have any questions, the Examiner is encouraged to
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`telephone the undersigned at (858) 350-2300. The Commissioner is hereby authorized to charge
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`any additional fees that may be required, or credit any overpayment to Deposit Account No. 23-
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`2415 (Attorney Docket No. 25922-819.301).
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`Respectfully submitted,
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`WILSON SONSINI GOODRICH & ROSATI
`Professional Corporation
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`By /Michael Hostetler/
`Michael J. Hostetler, Ph.D.
`Reg. No. 47,664
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`Date: December 17, 2013
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`650 Page Mill Road
`Palo Alto, CA 94304
`(858) 350-2300
`Customer No. 116469
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